open, randomised, multi-center study of on demand versus continuous esomeprazole treatment in patient with gerd

Conditions: Gastroesophageal Reflux

Summary: the purpose of this study is to compare on demand with continuous treatment of endoscopy negative subjects with gastroesophageal reflux disease (gerd), with esomeprazole 20-mg once daily, with regards to willingness to continue in the study as a result of satisfactory treatment over a six-month long term management period, after initial symptom relief.


Eligibility criteria:
inclusion criteria: * symptoms suggestive of gerd, with heartburn as their predominant symptom (described as a burning feeling, rising from the stomach or lower part of the chest up towards the neck), for longer than 6 months. * heartburn occurring for 4 days or more during the last 7 days prior to endoscopy. or, if ppi treatment has been started within the last 7 days prior to endoscopy, then heartburn occurring for 4 days or more during the last 7 days prior to start of ppi treatment * male or female, at least 18 years of age (for austria, at least 19 years of age) * have given written informed consent * ability to read and write (literate) * 7 symptom free (from heartburn) days in the last week prior to randomisation (day of visit not included) exclusion criteria: * documented esophageal mucosal break * history of esophageal, gastric or duodenal surgery, except closure and oversewing of an ulcer * chronic or recurrent abdominal pain associated with a chronic or recurrent bowel disturbance and/or bloating, that in the opinion of the investigator is likely to be due to irritable bowel syndrome or two or more of the following criteria: * symptoms relieved by defecation * symptoms associated with change in frequency of stools * symptoms associated with change in form of stools * any significant "alarm symptoms" such as unintentional weight loss, haematemesis melaena, jaundice or any other sign indicating serious or malignant disease. * subjects with current or historical evidence of the following diseases/conditions * zollinger ellison syndrome * primary esophageal motility disorder(s) i.e. achalasia, scleroderma, esophageal spasm * complications of gerd such as esophageal stricture, ulcer and/or macroscopic barrett's metaplasia (longer than 3 centimetres) or significant dysplastic changes in the esophagus * evidence of upper gastrointestinal malignancy at the screening endoscopy * gastric and/or duodenal ulcers within the last 2 years * malabsorption * malignancy, or significant cardiovascular, pulmonary, renal, pancreatic or liver disease as judged by the investigator * unstable diabetes mellitus. stable diabetes controlled on diet, oral agents or insulin is acceptable * cerebrovascular disease, such as cerebral ischemia, infarction, haemorrhage or embolus * subjects using a ppi for more than 10 days in the last 28 days, prior to endoscopy * use of ppis for more than 5 days in the last 7 days prior to endoscopy * subjects using daily h2-receptor antagonist, prokinetics recommended in the treatment of reflux symptoms or sucralfate during the 2 weeks prior to endoscopy and between the endoscopy and visit 1 and throughout the study * need for continuous concurrent therapy with * nsaids (including selective cox ii antagonists, salicylates (unless\<165 mg daily for cardiovascular prophylaxis) * anticholinergics * prostaglandin analogues * phenytoin * ketoconazole * itraconazole * warfarin and other vitamin k antagonists * pregnancy or lactation. women of childbearing potential must maintain effective contraception during the study period as judged by the investigator (for austria: women of child-bearing potential may only be included when their pregnancy status is assessed by the investigator prior to entry and then at monthly basis. for south-africa and spain: women of child-bearing potential may only be included when their pregnancy status is assessed by the investigator prior to endoscopy) * use of any other investigational compound 28 days prior to start and during the study * requirement of an interpreter (illiterate) * alcohol and/or drug abuse or any condition associated with poor compliance, including expected non-co-operation, as judged by the investigator * previous participation in this study * contra-indications to study drugs, e.g. known or suspected allergy to esomeprazole and any other constituents of the formulation. known hypersensitivity to substituted benzimidazole